HemoCue Albumin 201 User manual

HemoCue®Albumin 201
Operating Manual

3
Table of Contents
Intended use ...............................................................3
Components................................................................4
Start up.........................................................................6
Set-up Printer function .............................................8
Specimen Collection................................................10
Measurement ...........................................................12
Maintenance.............................................................18
Turbidity scale ...........................................................20
Troubleshooting Guide...........................................22
Specifications ............................................................30
Warranty and service ..............................................32

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HemoCue®Albumin 201 system Operating Manual
The HemoCue®Albumin 201 system consists of the HemoCue Albumin 201 Analyzer and HemoCue Urine Albumin Microcuvettes.
The system provides rapid, simple and reliable quantitative determination of albumin in urine with results that are precise and accurate.
The system can be used for the purpose of screening, for diagnosis, monitoring and supporting the clinical evidence in the treatment
of microalbuminuria.
This manual provides the basic instructions for routine use as well as technical specifications.
Additional information may be obtained from HemoCue America.
The HemoCue Albumin 201 System is classified as Waived under the CLIA Guidelines and can be used by all laboratories holding a CLIA
certificate of waiver. Please note that the complete test procedure should be read before performing the test. If the laboratory modifies the
HemoCue Albumin 201 test procedure, the test no longer meets the requirements for waived categorization. A modified test is considered to
be highly complex and is subject to all applicable CLIA requirements. For information on how to obtain a CLIA Waiver certificate, please refer
to CMS CLIA program.
!All system components are designed and manufactured to provide maximum safety. Any other use of the system may impair the safety.
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4
Components
12
4
3
5
6

5
4
1. The HemoCue Albumin 201
Analyzer*.
2. Power Adapter**.
3. Device for removing the cuvette
holder.
4. HemoCue Urine Albumin
Microcuvettes***.
5. HemoCue Albumin 201
Operating Manual, Quick
Reference Guide and Instruction
CD.
6. HemoCue Cleaner.
The HemoCue Albumin 201
Analyzer and a power adapter are
delivered in a carton. Open the car-
ton on a stable surface and lift out
the analyzer and the accessories.
* Do not open the cover of the
analyzer. Note: The warranty will be
voided if the cover of the analyzer
has been opened.
** Only use adapters, as listed
under specifications.
*** Not included.
For infomation about HemoCue
Urine Albumin Microcuvettes
please contact HemoCue America.
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Start-up
1
2a
3
4
2b

7
6
1. Attach the power adapter to the
”POWER INLET” at the back of the
analyzer. Make sure that the lid on
top of the analyzer is closed.
2. a. Serial port. The analyzer can be
connected to a printer (for further
information, see Set up Printer func-
tion).
2. b. USB port. (Used for PC-connection
– only outside US)
3. Press and hold the left button until
the display is activated (all symbols
appear on the display). The display
shows the version number of the
program, audio signal and the
HemoCue symbol. During this time
the analyzer will automatically verify
the performance of the optical unit.
4. After this the display will show three
flashing dashes. This indicates that
the HemoCue Albumin 201 Analyzer
is ready for use.
To turn the analyzer off, press and hold
the left button until the display reads
OFF and then goes blank. Disconnect
the analyzer from the power source by
removing the power adapter from the
outlet.
Note! Make sure that the lid is closed.
If the lid is open for more than one
minute, the display will show ”U-A”.
Once the lid is closed, the analyzer will
perform an electronic “self test”.
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8
Set-up Printer function
1
3

9
8
The analyzer can be on or off when
connecting the printer to the analyzer.
A printer can be used to print out
the current result immediately after
completion of the measurement.
Previously obtained results cannot be
printed.
1. Connect the cable* to the analyzer
and printer*.
2. Perform the analysis by following
the steps 1-6 in Measurement.
3. When the result is shown on the
display, the printer will automatically
print the result.
Note! Only use ASCII printers.
Contact HemoCue America for informa-
tion.
*Not included.
The following comport settings are used:
• Baudrite 9600
• Databits 8
• Parity None
• Stopbits 1
• Flowcontrol None
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Specimen collection U-Albumin – Spot urine, morning urine

11
10
Specimen collection
Spot urine, preferably the first
morning urine may be used.
Specimen collection for
U-Albumin, spot urine
Collect the first morning urine.
The analysis is performed as
described below. The result is
read directly from the instru-
ment in mg/L.
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Measurement
1 2

13
12
Open the microcuvette package and
carefully remove the cuvette.
Pipette a drop of urine onto a hydropho-
bic surface (for example,Parafilm).
It is also possible to fill the cuvette direct-
ly from the sample, if it is not to be used
for any other analysis.
1. Hold the cuvette opposite the
filling end. The filling end is
brought into contact with the
urine sample. Allow the cavity
of the cuvette to fill completely
in one step. Do NOT refill the
cuvette! Always avoid con-
tamination of the outside of the
cuvette.
2. When completely filled, carefully
wipe off the excess urine from
the outside of the cuvette with
a clean lint free wipe. Make sure
that no sample is drawn out of
the cuvette during this proce-
dure. The filled cuvette should
be visually inspected to check
that the cuvette is properly
filled, i.e. completely filled up to
the edge and without air bubbles
in the optical eye. If air bubbles
are seen in the optical eye of a
filled cuvette, discard the cuvette
and fill another cuvette from a
second drop of specimen.
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Measurement
3a 3b
3c
4 5

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3. Open the lid and place the filled
cuvette into the cuvette holder
(3a). It is important that the
cuvette “snaps” properly into
the cuvette holder (3b). Start
measurement as soon as possible
but no later than 30 seconds
after filling the microcuvette by
gently closing the lid (3c).
4. During measurement the hour
glass 6is displayed with three
fixed dashes.
5. Within 90 seconds, the result is
displayed in mg/L. The result will
remain on the display until the
lid is opened.
Measurements below 7 mg/L are
displayed as “LLL”.
Measurements above 150 mg/L
are displayed as “HHH”.
If the display shows an error
code, an error has occurred.
See the Troubleshooting Guide.
Do not remeasure the cuvette.
Note that the measurement is
not completed until the steps
in paragraph 8have been per-
formed and the display shows
three flashing dashes.

6b
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16
Measurement
6a 6c

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16
6. a, b, c. Open the lid and discard
the cuvette. Close the lid and
wait until three flashing dashes
are shown in the display.
7. Although the reagents are pres-
ent in the cuvette in extremely
low quantities, consult local
environmental authorities for
proper disposal.Always handle
urine with care, as it might be
infectious.
When the measurements for
the day have been completed,
switch off the analyzer with the
ON/OFF button.
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Maintenance
1
2
3
4

19
18
The cuvette holder should be cleaned
after each day of use. The cover
glasses of the optical unit should be
cleaned when directed to do so in the
Troubleshooting Guide.
Make sure that the analyzer is switched
off and that the display is blank.
Open the lid.
1. The cuvette holder is released by
pressing the area marked with
arrows using the device included
with the system.
2. Press the tab downwards and
draw the cuvette holder towards
you until it becomes detached.
Use a mild detergent or alcohol to
clean the cuvette holder.
3. The cover glasses of the optical
unit, both beneath and above the
cuvette holder area, may be cleaned
using the HemoCue Cleaner*. If a
HemoCue Cleaner is not available,
a cotton tipped swab moistured
with water or alcohol without
additives may be used.
4. Wait 15 minutes before replac-
ing the cuvette holder.
Use alcohol or mild soap deter-
gent for cleaning the outer sur-
face of the instrument.
* One HemoCue Cleaner is included
with the analyzer. Contact HemoCue
America to order more.
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Turbidity scale
20
20 21